Toxicological Expert Job at FMS USA Fresenius Mgmt Services Inc (St. Wendel)

Biocompatibility & Toxicological Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , Bad Homburg

Salary:

Not provided

Fresenius Kidney Care Eupora

Expiration Date

Until further notice

Requirements

Successfully completed master's degree in toxicology, chemistry, physics, life sciences, engineering, or a related field
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Solid expertise in biocompatibility evaluation and toxicological risk assessment
Experience in project management or cross-functional coordination
Strong knowledge of medical device regulations and standards (e.g. MDR 2017/745, ISO 13485, ISO 14971, ISO 10993 series, FDA 21 CFR Part 820)
Good understanding of global quality management systems and regulatory environments
Strong analytical skills, structured working style, and experience in scientific writing
knowledge of statistical methods is a plus
Ability to work independently and lead cross-functional topics without direct disciplinary authority
Proactive, solution-oriented mindset with strong organizational and communication skills

Job Responsibility

Lead biocompatibility and toxicology activities for a global medical device platform, including active devices and disposables
Define and drive the overall strategy for biological safety and toxicological evaluation across the product lifecycle
Take end-to-end accountability for key deliverables (e.g. biological evaluation plans/reports, toxicological risk assessments) in alignment with internal experts
Act as the central interface for cross-functional stakeholders, aligning requirements and prioritizing activities
Ensure compliant safety and risk assessments based on materials, extractables & leachables, and biocompatibility studies (ISO 10993)
Provide expert guidance and scientific assessments to support product development and regulatory submissions
Coordinate global biocompatibility activities and collaborate with internal competence centers, EHS, and Quality & Regulatory teams
Contribute to design control, regulatory compliance, and continuous improvement initiatives, including sustainability aspects

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fulltime

Senior Biocompatibility & Toxicological Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , Bad Homburg

Salary:

Not provided

FMS USA Fresenius Mgmt Services Inc

Expiration Date

Until further notice

Requirements

Successfully completed master's degree in toxicology, chemistry, physics, life sciences, engineering, or a related field
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Solid expertise in biocompatibility evaluation and toxicological risk assessment
Experience in project management or cross-functional coordination
Strong knowledge of medical device regulations and standards (e.g. MDR 2017/745, ISO 13485, ISO 14971, ISO 10993 series, FDA 21 CFR Part 820)
Good understanding of global quality management systems and regulatory environments
Strong analytical skills, structured working style, and experience in scientific writing
knowledge of statistical methods is a plus
Ability to work independently and lead cross-functional topics without direct disciplinary authority
Proactive, solution-oriented mindset with strong organizational and communication skills

Job Responsibility

Lead biocompatibility and toxicology activities for a global medical device platform, including active devices and disposables
Define and drive the overall strategy for biological safety and toxicological evaluation across the product lifecycle
Take end-to-end accountability for key deliverables (e.g. biological evaluation plans/reports, toxicological risk assessments) in alignment with internal experts
Act as the central interface for cross-functional stakeholders, aligning requirements and prioritizing activities
Ensure compliant safety and risk assessments based on materials, extractables & leachables, and biocompatibility studies (ISO 10993)
Provide expert guidance and scientific assessments to support product development and regulatory submissions
Coordinate global biocompatibility activities and collaborate with internal competence centers, EHS, and Quality & Regulatory teams
Contribute to design control, regulatory compliance, and continuous improvement initiatives, including sustainability aspects

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fulltime

Senior Research Scientist - Toxicology

We are looking for a dynamic and detail-oriented Senior Research Scientist to jo...

Location

Canada , Vancouver

Salary:

112000.00 - 150000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

PhD in Toxicology or a related field, and a minimum of 5-8 years of related industry experience supporting biologics development
candidates with a MSc and 10+ years of relevant experience will also be considered
extensive hands-on experience with in vitro and/or in vivo toxicology studies
demonstrated proficiency with nonclinical safety assessment of large molecules/ biologics
strong organizational, critical problem-solving, and analytical skills to assess complex datasets and propose strategic solutions
excellent scientific writing, communication, and collaboration skills to effectively lead scientific discussions and influence decision-making
DABT accreditation (highly desirable, but not required)

Job Responsibility

Leading the design, planning, and oversight of in vitro safety and/or in vivo toxicology studies, ensuring alignment with global regulatory guidelines and strategic company objectives
Serving as a subject matter expert (SME) for Nonclinical Safety within cross-functional project teams, actively representing the function in internal and external stakeholder meetings
Providing critical assessment of complex toxicology data, translating and communicating clear, actionable risk-benefit evaluations and strategic recommendations to project teams and executive leadership
Maintaining comprehensive and meticulous recording of nonclinical safety study data as required by Good Laboratory Practice (GLP)
Authoring and critically reviewing the in vitro safety, toxicology, and safety pharmacology sections of Regulatory documentation (such as INDs, CTAs, IBs, and BLAs)
Collaborating seamlessly with scientists across various matrixed teams at AbCellera to ensure high data quality and accelerate program advancement
Contributing to the development of our toxicology programs and performing as a nonclinical safety/toxicology representative as needed
Maintaining an active scan and synthesis of published toxicology literature and evolving regulatory guidance relevant to AbCellera’s product portfolio, translating insights into internal best practices

What we offer

Equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits
Scientific and technical mentorship
strong sense of community and connections through work, clubs, and socials

Fulltime

Senior Environmental Engineer: Fluids Management Specialist Lead

The Fluids Management Specialist is the single-point authority for General Motor...

Location

United States

Salary:

Not provided

General Motors

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Materials/Metallurgical Engineering, Environmental Engineering, Chemistry, or a related technical field
Typically 5+ years of experience in manufacturing, chemical management, metalworking fluids, or related process engineering
Experience with industrial coolant/MRF systems or lubrication systems
Experience with health, safety, and environmental considerations for chemicals in manufacturing
Demonstrated cross-functional technical leadership and decision-making
Proven ability to apply corporate standards and regulatory requirements to technical and business decisions

Job Responsibility

Lead the MRFST and ensure corporate, Manufacturing Engineering, and GPS MRF requirements are met
Develop, maintain, and enforce MRF policies and management guidelines for GPS plants
Ensure plant compliance with approved best practices, biostability requirements, and chemical management standards
Serve as the central authority on MRF, biostability, and coolant management requirements
Drive standardized, biostable coolant strategies across GPS operations
Approve or reject all new and expanded-use MRFs before PMRv and Plant CCC submission
Ensure all MRFs on the PMRv list receive formal MRFST approval before plant use
Provide technical oversight to Chemical Managers supporting the PMRv process
Maintain the official list of MRFST- and LS2-approved fluids
Lead the two-phase MRF review process

Fulltime

Associate Director / Director, Toxicology

Beam is looking for a highly talented and motivated Associate Director / Directo...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Ph.D. with 8+ years of scientific experience OR MS with 12+ years of scientific experience. BS with 15+ years of scientific experience in preclinical toxicology will also be considered
Experience with LNPs and/or gene therapies
Ability to develop and deliver clear and concise presentations for both internal and external meetings
In-depth understanding of all aspects of nonclinical safety and experience with regulatory filings
Extensive knowledge of relevant FDA and EMEA regulations and processes
Demonstrated proven experience in working with CROs for protocol design and study execution
Experience working with cross-functional and collaborative project teams
Ability to operate effectively within an innovative and science-driven company environment
delivery-oriented, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards

Job Responsibility

Work cross-functionally to drive nonclinical safety related activities from discovery through regulatory filings and to commercialization for various programs
Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, resources and budgets
Coordinate interactions with CRO's, in collaboration with the Nonclinical Development Operations group, to ensure delivery of study results and reports consistent with program timelines
Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting development and platform programs
Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications, and help resolve nonclinical safety queries
Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets
Serve as the toxicology representative in cross-functional meetings both internally and externally

Fulltime

Study Director - Extractables & Leachables

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or Master’s degree with 5–7 years, or PhD with 3+ years of experience in a related field
Demonstrated experience in Extractables & Leachables studies
Strong background in analytical method development and validation
Solid knowledge of analytical techniques such as LC/MS/UV, GC/MS/FID, and ICP‑MS
Experience with chemical characterization standards for medical devices and container closure systems
Familiarity with global E&L regulatory expectations, particularly for medical devices and drug product packaging
Strong scientific judgment and critical thinking
Ability to lead complex studies with autonomy and rigor
Excellent communication and collaboration skills
Comfortable working in cross‑functional, multicultural teams

Job Responsibility

Design, direct, and oversee extractables and leachables studies for medical devices and drug product packaging
Author and review study protocols, reports, and technical documentation, incorporating input from subject matter experts
Lead method development, validation, and transfer activities in collaboration with internal teams and external laboratories
Develop E&L strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations
Ensure scientific justification of study designs and results to support innovative and compliant products
Review and interpret E&L data, identifying trends and correlations with materials of construction
Drive the structural identification of extractables and leachables
Collaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments
Work cross‑functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners
Participate in regulatory interactions, including submissions, pre‑submission meetings, and responses to authority questions

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Senior Director, Nonclinical Safety Evaluation

At Moderna, our mission is to deliver the greatest possible impact to people thr...

Location

United States , Cambridge

Salary:

196700.00 - 353400.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

PhD & 11 or more years spent overseeing aspects of nonclinical safety assessment activities in pharmaceutical development
Experience serving in and/or managing colleagues serving in the capacity of a Toxicology representative role on drug development programs in the pharmaceutical/biotechnology industry and corresponding experience in designing and executing nonclinical toxicology strategies and GLP/non-GLP studies to support clinical development and regulatory submissions
Experience in mentoring, coaching, and/or managing others
Experience applying regulatory guideline knowledge in the conduct of nonclinical safety studies to support regulatory filings
Direct experience in writing, reviewing, and critiquing nonclinical sections of regulatory submission documents (e.g., INDs/CTAs/BLAs/MAAs, briefing documents, regulatory query responses) and interacting with regulatory agencies
Passion for people management, team building, and creative solution seeking for organizational development
Outstanding written and verbal communication skills and the ability to develop and deliver clear and concise presentations for both internal and external stakeholders
Attention to detail and quality, and ability to deliver work on time
Demonstrated ability to work successfully in a fast-paced and dynamic work environment, with the agility to quickly pivot in the face of new data and/or strategic directions
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Job Responsibility

Provide direct and matrix management of a high performing team of Toxicologists and Pathologists
Provide integrated strategic leadership for Toxicology and Pathology in support of nonclinical safety evaluation
Apply in-depth knowledge of how nonclinical safety disciplines integrate with other areas across the business
Evaluate non-clinical safety challenges in a complex or fast-changing environment and direct the development of new or innovative solutions
Provide strategic oversight on and coach/guide team members on the development of scientifically-sound nonclinical safety strategies
Accountable for the design, execution, critical analysis, and reporting of GLP/non-GLP nonclinical safety in vitro and/or in vivo studies
May be accountable for toxicology assessments supporting extractable/leachable and contaminant risk assessments and/or impurity qualification
Serve as a key scientific contributor in regulatory agency interactions
Apply expert scientific and regulatory writing experience when critically reviewing, editing, and authoring submission application documents
Oversee the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal/external partners and/or scientific groups

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Annual discretionary bonus, other incentive compensation, or equity award

Fulltime

Director DMPK

Are you ready to make a groundbreaking impact in the world of biotechnology? Joi...

Location

United States , Palo Alto

Salary:

190000.00 - 240000.00 USD / Year

Proclinical

Expiration Date

Until further notice

Requirements

Advanced degree (PhD) in pharmacokinetics, drug metabolism, or a related field
Expertise in small-molecule DMPK with experience spanning discovery and development
Proficiency in analyzing PK and PK-PD data using relevant software tools
Strong understanding of regulatory guidelines for small-molecule drug development
Experience preparing regulatory submissions and interacting with regulatory agencies
Ability to oversee bioanalytical method development and validation
Excellent communication, analytical, and problem-solving skills
Leadership capabilities with a detail-oriented and adaptable approach in a fast-paced environment

Job Responsibility

Develop and implement DMPK and PK-PD strategies aligned with discovery and development goals
Serve as the DMPK program lead, overseeing study design, execution, data analysis, interpretation, and reporting
Provide expert insights on DMPK data and present findings to project teams, senior leadership, and external stakeholders
Collaborate with cross-functional teams, including medicinal chemistry, toxicology, pharmacology, CMC, and clinical groups, to support data-driven decision-making
Manage bioanalytical and DMPK studies conducted internally and through external partners (CROs)
Author and review DMPK-related sections of regulatory documents such as IND, IB, CTA, NDA, and BLA, and address regulatory inquiries
Support clinical pharmacology activities, including first-in-human dose projections
Ensure high standards of scientific rigor, quality, and documentation throughout all processes

Fulltime

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Toxicological Expert

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